FDA approves AbbVie's once-daily Parkinson's drug Juvmo (tavapadon)

The US Food and Drug Administration has approved Juvmo (tavapadon), an AbbVie pill for treating Parkinson's disease in adults, the company announced on September 28, 2026. AbbVie says Juvmo is the first and only selective D1/D5 receptor agonist approved for the condition, and that it expects the drug to be available in the US in October 2026.

How the drug works

Tavapadon is a dopamine agonist. The Michael J. Fox Foundation describes the class this way: "Tavapadon is a dopamine agonist — a class of Parkinson's drugs that mimics dopamine, the brain chemical that becomes depleted in Parkinson's."

According to AbbVie, Juvmo targets D1 and D5 dopamine receptors, which differs from existing dopamine agonists that act selectively on D2 and D3 receptors. It is taken once a day by mouth, either on its own or together with levodopa. It comes in 5 mg, 10 mg and 15 mg tablets, with a titration pack containing 0.25 mg and 1 mg tablets, Drug Topics reported.

What the trials found

The approval was based on the TEMPO clinical trial program. Drug Topics reported that TEMPO-1 enrolled 529 adults with early Parkinson's disease, and TEMPO-3 enrolled 507 adults who experienced motor fluctuations while taking levodopa.

In TEMPO-3, according to AbbVie, daily 'on' time without dyskinesia, a type of involuntary movement, increased by 1.7 hours with tavapadon compared with 0.6 hours with placebo. The Michael J. Fox Foundation summarized the add-on results as roughly one more hour of improved symptom control per day and about one hour less 'off' time.

Side effects were common. Medical Daily reported that in TEMPO-1, 64 of 354 patients taking the drug (18.1%) stopped treatment because of adverse events, compared with 7 of 175 on placebo (4.0%). In TEMPO-2, nausea occurred in 30% of patients, headache in 17% and dizziness in 16%, according to Medical Daily. AbbVie lists orthostatic hypotension, hallucinations, dyskinesia and unusual urges among the more serious safety concerns.

Dr. Hubert Fernandez of Cleveland Clinic told Medical Daily that side effects of interest such as sudden sleep attacks and impulse control problems were more common with older D2 agonists: "D1-targeting drugs are not exempt, but the representation of adverse effects of interest was much higher with D2 agonists."

What the company and advocates said

"The approval of Juvmo marks the first dopaminergic breakthrough for Parkinson disease in decades," said Roopal Thakkar, AbbVie's chief scientific officer, according to Drug Topics. That is AbbVie's own description of the drug.

Brian Fiske of the Michael J. Fox Foundation said: "Each therapy approval is an important milestone in building a diverse treatment pipeline." The foundation says it does not endorse specific drug therapies and that treatment decisions should be made with qualified health care professionals.

Why it matters

Medical Daily reports that more than 11 million people worldwide live with Parkinson's disease. Juvmo adds a new type of dopamine-targeting treatment for motor symptoms, for use in early disease or alongside levodopa. Its trials lasted about six months each, and longer-term data come from an extension study, TEMPO-4.

Sources

This article was drafted with AI assistance and checked against the sources above. Company claims are reported as claims. Cover image is AI-generated.